Pediatric Consultants Of Lenoir City

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: =================================== Based on a review of the Laboratory's Procedure, Calibration Verification records for the Hematology analyzer and upon interview with the Lead Testing Personnel and Laboratory Director determined the laboratory failed to ensure calibration verification was performed at six month intervals for 2021 and 2022. The findings include: 1. A review of the Laboratory's Procedure titled, "CBC Machine" stated calibration to be done every six Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- months. 2. A review of Calibration Verification records for the hematology analyzer revealed calibration verification performed on 09.09.2021 and 05.04.2022, therefore the laboratory failed to perform calibration verification at six month intervals. 2. An interview with the Lead Testing Personnel and Laboratory Director at 11:30 a.m. on October 10, 2022 confirmed calibration verification was not performed on the hematology analyzer at six month intervals for 2021 and 2022. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for the analytes hemoglobin (HGB), white blood cells (WBC), platelets (PLT), mean corpuscular hemoglobin(MCH), and mean corpuscular volume (MCV), resulting in the first nsuccessful proficiency testing (PT) occurrence for HGB, WBC, & PLT. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155 (CMS 0155D) and American Proficiency Testing (API) performance summary, the laboratory failed to maintain satisfactory performance in Red Blood Cell (RBC) and Hematocrit (HCT) for the 2nd and 3rd events 2020 and 1st event 2021, resulting in the SECOND unsuccessful performance occurrence. The findings include: 1. A review of the CMS 0155D report for 2020 revealed the RBC Scores for event two = 0% and for event three = 60%, and HCT scores for event two = 0% and for event three = 40%. 2. A review of the CMS 0155D report for 2021 revealed the RBC and HCT scores for event one = 60%. 3. A review of the 2020 API PT Performance Summary for event two revealed RBC and HCT were graded as unsatisfactory with scores of 0%. 4. A review of the 2020 API PT Performance Summary for event three revealed the RBC was graded as unsatisfactory with a score of 60% and HCT was graded as unsatisfactory with a score of 40%. 5. A review of the 2021 API PT Performance Summary for event one revealed RBC and HCT were graded as unsatisfactory with scores of 60% resulting in the SECOND Unsuccessful PT occurrence. =================================== D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: =================================== The Laboratory Director failed to provide direction for successful Proficiency Testing (PT) Participation in Three of Three Events for Hematology in 2020 and 2021 resulting in the SECOND Unsuccessful PT occurrence (Reference D6004). =================================== D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: =================================== Based on review of the CMS 0155D Report and the Americn Proficiency Institute (API) PT Program Evaluation Report of the Unsatisfactory Scores for Hematology for three of three events for 2020 and 2021, determined the Laboratory Director failed to provide effective direction over Proficiency Testing for Red Blood Cell (RBC) and Hematocrit (HCT) in 2020 and 2021, resulting in the SECOND UNSUCCESSFUL Proficiency Testing performance. The findings include: 1. A review of the CMS 0155D report for 2020 revealed event two as Unsatisfactory with scores of 0% for both RBC and HCT; event three as Unsatisfactory with a score of 60% for RBC and 40% for HCT and event one of 2021 as Unsatisfactory with scores of 60% for both RBC and HCT, resulting in the SECOND UNSUCCESSFUL occurrence for RBC and HCT. 2. A review of the API PT Evaluation Report for 2020 revealed event two as Unsatisfactory with scores of 0% for both RBC and HCT; event three as Unsatisfactory with a score of 60% for RBC and 40% for HCT and event one of 2021 as Unsatisfactory with scores of 60% for both RBC and HCT, resulting in the SECOND UNSUCCESSFUL occurrence for RBC and HCT which determined the Laboratory Director failed to provide effective direction over Proficiency Testing for RBC and HCT in 2020 and 2021 resulting in the SECOND UNSUCCESSFUL Proficiency Testing performance. =================================== -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for the analytes hemoglobin (HGB), white blood cells (WBC), platelets (PLT), mean corpuscular hemoglobin(MCH), and mean corpuscular volume (MCV), resulting in the first nsuccessful proficiency testing (PT) occurrence for HGB, WBC, & PLT. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2020 and 2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the analytes Hemoglobin (HGB), White Blood Cells (WBC), Platelets (PLT), mean corpuscular hemoglobin (MCH), and mean corpuscular volume (MCV) in the 2nd event of 2020 and 1st event of 2021, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed the scores for the analytes HGB, WBC's, PLT's, MCH, and MCV for the 2nd event of 2020 were 0% and for the 1st event of 2021 were 60%. 2. A review of the laboratory's 2020 API Proficiency Testing records revealed the 2nd event had unacceptable performance scores of 0% for HGB, WBC's, PLT's, MCH, and MCV. 3. A review of the laboratory's 2021 API Proficiency Testing records revealed the 1st event had unacceptable performance scores of 60% for HGB, WBC's, PLT's, MCH, and MCV resulting in the first unsuccessful PT occurrence. =================================== D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: =================================== The Laboratory Director failed to provide direction for successful Proficiency Testing (PT) Participation in Three of Three Events for Hematology in 2020 and 2021 resulting in the SECOND Unsuccessful PT occurrence (Reference D6004). =================================== D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: -- 2 of 3 -- =================================== Based on review of the CMS 0155D Report and the Americn Proficiency Institute (API) PT Program Evaluation Report of the Unsatisfactory Scores for Hematology for three of three events for 2020 and 2021, determined the Laboratory Director failed to provide effective direction over Proficiency Testing for Red Blood Cell (RBC) and Hematocrit (HCT) in 2020 and 2021, resulting in the SECOND UNSUCCESSFUL Proficiency Testing performance. The findings include: 1. A review of the CMS 0155D report for 2020 revealed event two as Unsatisfactory with scores of 0% for both RBC and HCT; event three as Unsatisfactory with a score of 60% for RBC and 40% for HCT and event one of 2021 as Unsatisfactory with scores of 60% for both RBC and HCT, resulting in the SECOND UNSUCCESSFUL occurrence for RBC and HCT. 2. A review of the API PT Evaluation Report for 2020 revealed event two as Unsatisfactory with scores of 0% for both RBC and HCT; event three as Unsatisfactory with a score of 60% for RBC and 40% for HCT and event one of 2021 as Unsatisfactory with scores of 60% for both RBC and HCT, resulting in the SECOND UNSUCCESSFUL occurrence for RBC and HCT which determined the Laboratory Director failed to provide effective direction over Proficiency Testing for RBC and HCT in 2020 and 2021 resulting in the SECOND UNSUCCESSFUL Proficiency Testing performance. =================================== -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for red blood cell (RBC) and hematocrit (HCT) analytes, resulting in the first unsuccessful proficiency testing (PT) occurrence for RBC and HCT. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2020 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Red Blood Cell (RBC) and Hematocrit (HCT) analytes in the 2nd and 3rd events of 2020, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed the score for the RBC analyte for the 2nd event of 2020 was 0% and for the 3rd event of 2020 was 60% and score for the HCT analyte for the 2nd event was 0% and for the 3rd event was 40%. 2. A review of the laboratory's 2020 API Proficiency Testing records revealed the 2nd event had unacceptable performance for RBC resulting in a 0% score and for HCT resulting in a 0% score. 3. A review of the laboratory's 2020 API Proficiency Testing records revealed the 3rd event had unacceptable performance for RBC resulting in a 60% score and for HCT resulting in a 40% score, resulting in the first unsuccessful PT occurrence. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: =================================== Based on review of Proficiency Testing (PT) reports for 2018 and 2019, attestation sheets that lacked laboratory director signatures and upon interview with laboratory director and nursing supervisor, determined the laboratory director failed to sign attestation sheets for CBC (Complete Blood Count) testing. The findings include: 1. Review of PT reports for 2018 and 2019. 2. Review of attestation sheets revealed lack of laboratory director signatures for the second and third event of 2018 and the first event of 2019. 3. Interview at approximately 4:00 p.m. August 13, 2019 with laboratory director and nursing supervisor confirmed the PT attestation sheets for 2018 and 2019 lacked laboratory director signatures for CBC testing. =================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --